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Clopidogrel and aspirin therapy was proven to be effective in the CURE trial for patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI) who were conservatively managed.1 The combination is currently recommended for UA/NSTEMI in the latest ACCF/AHA guidelines.2 Clopidogrel and aspirin decreases the combined clinical outcome of death from cardiovascular causes, nonfatal MI, or stroke, however it also increases the risk of bleeding.1 Prasugrel is a new thienopyridine which was FDA approved in 2009 for use in patients with acute coronary syndrome (ACS) who are undergoing a percutaneous coronary intervention (PCI).3 The TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial investigated whether prasugrel would be superior to clopidogrel in patients on aspirin with UA/NSTEMI who were being managed medically.4

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The TRILOGY ACS study was a randomized, double-blind, double-dummy, active-control, event-driven trial.4 Patients with UA or NSTEMI who were being managed medically were randomized to receive prasugrel or clopidogrel if they met at least one of the following criteria: age at least 60 years, presence of diabetes, prior MI, or prior revascularization with either PCI or CABG. The exclusion criteria included a history of TIA or stroke, PCI or CABG within the previous 30 days, renal failure and concomitant use of an oral anticoagulant. Patients who were clopidogrel naïve received a loading dose of either 30 mg of prasugrel or 300 mg of clopidogrel. The prasugrel maintenance dose was 10 mg daily, but was reduced to 5 mg for patients 75 years or older or who weighed less than 60 kg. All patients in the clopidogrel arm received a daily dose of 75mg. The concomitant use of aspirin was required, with a dose of 100mg or less being strongly recommended. The primary endpoint of the TRILOGY ACS trial was a composite death from cardiovascular causes, nonfatal MI or nonfatal stroke among patients less than 75 years of age. This endpoint was also evaluated for patients 75 years or older but as a secondary analysis which was not be reported in the trial. The primary safety endpoint was bleeding which was measured by the GUSTO and TIMI scales.4

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There were 7243 patients included in the primary analysis of patients less than 75 years of age with the median age being 62 years.4 The median follow up was 17 months, with a maximum follow up of 30 months. No statistical difference was found in the primary endpoint with an occurrence in 13.9% of patients in the prasugrel group and 16.0% of the clopidogrel group (HR 0.91, CI, 0.79 – 1.05, P=0.21). A weak non-significant trend toward a reduction in the primary clinical endpoint was observed with prasugrel after twelve months of treatment (P=0.07) in a post-hoc analysis. The rate of major bleeding was similar in both groups; however, more minor and moderate bleeding was observed with prasugrel.4 

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The TRIOLOGY ...

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